Delivering IND‑ready packages and late‑stage process optimization through practical, science‑driven strategy. We align molecule, process, and organization to achieve accelerated clinical milestones and robust regulatory outcomes.
Start a conversationFirst Principles CMC partners with emerging biotech teams to convert innovation into reliable, manufacturable therapies. We build technical and operational systems that scale with your company—ensuring disciplined execution, integrated control strategies, and regulatory credibility from IND to BLA.
Designing and scaling Technical Operations organizations aligned with company growth stage—from lean start‑up execution to late‑stage readiness.
Global CDMO selection, tech transfer, and governance frameworks that ensure reliable supply and capital‑efficient execution.
Risk‑based QbD frameworks ensuring deep process understanding, consistent product quality, and accelerated regulatory acceptance.
Coordinated authoring and review of global CMC submissions—IND/IMPD/CTA through late‑stage readiness—with technically sound, defensible documentation.
Translating research to GMP with lifecycle optimization, comparability, and validation planning aligned to accelerated approval options.
Global MSAT leadership and deviation/CPV frameworks that preserve regulatory posture through commercialization.
Delivery Signals
Benjamin Hutchins, PhD is a Technical Operations executive with 15+ years of experience in biologics and ADC development. He builds teams, systems, and strategies that convert science into reliable clinical and commercial supply, with expertise in CMC strategy, process optimization, and lifecycle regulatory design.